Table 3.
Individual adverse events in the East Asian population of the targeted investigational treatment analysis of novel anti-androgen trial (safety population)
| Event | Apalutamide (total=110), n (%) | Placebo (total=110), n (%) | ||
|---|---|---|---|---|
|
|
|
|||
| Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 | |
| AE reported in ≥10% of patients | ||||
| Hypertension | 25 (22.7) | 12 (10.9) | 16 (14.5) | 9 (8.2) |
| Weight increased | 24 (21.8) | 4 (3.6) | 40 (36.4) | 4 (3.6) |
| Weight decreased | 20 (18.2) | 1 (0.9) | 5 (4.5) | 0 (0) |
| Pruritus | 19 (17.3) | 0 (0) | 9 (8.2) | 0 (0) |
| Hot flush | 18 (16.4) | 0 (0) | 11 (10.0) | 0 (0) |
| Upper respiratory tract infection | 16 (14.5) | 1 (0.9) | 11 (10.0) | 1 (0.9) |
| Viral upper respiratory tract infection | 14 (12.7) | 0 (0) | 13 (11.8) | 0 (0) |
| Arthralgia | 14 (12.7) | 0 (0) | 12 (10.9) | 0 (0) |
| Constipation | 13 (11.8) | 0 (0) | 10 (9.1) | 0 (0) |
| Pain in arm or leg | 12 (10.9) | 0 (0) | 16 (14.5) | 1 (0.9) |
| Rash, generalized | 11 (10.0) | 4 (3.6) | 1 (0.9) | 0 (0) |
| AE of special interest | ||||
| Rash | 41 (37.3) | 12 (10.9) | 10 (9.1) | 1 (0.9) |
| Fall | 3 (2.7) | 0 (0) | 5 (4.5) | 0 (0) |
| Fracture | 6 (5.5) | 1 (0.9) | 7 (6.4) | 2 (1.8) |
| Hypothyroidism | 5 (4.5) | 0 (0) | 0 (0) | 0 (0) |
AE: adverse event